MAUDE Adverse Event Report: COVIDIEN LP SPACEMAKER; LAPAROSCOPE, GENERAL PLASTIC SURGERY

Model Number SMSBTOVLX

Device Problem Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/16/2018

Event Type  malfunction  

Event Description

After opening trocar, it was discovered that balloon was not sealed onto trocar.

• Brand Name: SPACEMAKER
• Type of Device: LAPAROSCOPE, GENERAL PLASTIC SURGERY
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 8054581
• MDR Text Key: 126646128
• Report Number: 8054581
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 10884521545311
• UDI-Public: (01)10884521545311(17)200531(10)P8E1233X
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: SMSBTOVLX
• Device Catalogue Number: SMSBTOVLX
• Device Lot Number: P8E1233X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/02/2018
• Event Location: Hospital
• Date Report to Manufacturer: 11/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1